The Factors Effecting Prefilled Syringe Filling Machine
Prefilled syringe machines are devices that automate the process of filling syringes with a pre-measured dose of medication. These machines are commonly used in the pharmaceutical industry for the production of injectable drugs, vaccines, and other medical products.
The prefilled syringe machine typically consists of a number of components, including a syringe loading station, a dosing station, a stoppering station, and a plunger inserting with labeling station. The syringe loading station is responsible for loading empty syringes into the machine, while the dosing station measures the correct dose of medication and fills the syringe. The stoppering station then seals the syringe with rubber stopper, The plunger inserting and labeling station applies a Plunger rod and label to the syringe.
There will be few issues for Prefilled syringe filling process need the production person to be noticed, such as Raw Material Viscosity, Syringe Material, Stopper Material, Filling Accuracy, Bubble Issue while filling, Temperature, Inspection and Terminal Sterilization.
How Raw Material Viscosity will affect prefilled syringe machine?
According to different injectable solution, there are mainly three types of Viscosity range of raw material. Such as Water-Like Solution 1-50Cps, Oil-Like Solution 50-600cps, high viscosity Gel-Like Solution 600-12,000cps.
So select a correct filling pump for syringe filling will be very necessary and critical. A wrong filling pump will cause Bubble Syringe, Incorrect Filling Syringe and non-cleanness filling. Especially for high viscosity material, normally the raw material itself is extremely expensive, you can not choose a filling pump with high waste filling to increase your production investment.
The suggestion for pump selection on different viscosity syringe filling, Below 10ml filling capacity can be used Ceramic Piston pump for all viscosity material. But if a high viscosity filling with extreme raw material below 2ml, we will suggest you to use Minor dosing Syringe Pump with 0.5% filling accuracy. A Tri-Way Ceramic pump is also an option for high viscosity filling below 10ml, but cleaning process will waste some raw material for increasing production expense.
For easy flow material, Water-Like Solution, you can also choose Peristaltic Pump for saving initial equipment investment. Filling accuracy could be around 2% for 10ml syringe.
How Syringe material will affect Prefilled syringe production efficiency?
Nowadays in the market, there are two kinds of syringe material: Glass Syringe and Plastic Syringe. Due to different usage of the product, normally glass syringes are used for injectables, as plastic syringes are used for oral and outer usage. Of course, recently in Germany and Japanese manufacturers they developed COP and COC plastic syringes are used for injectable sterile medicine which had been validated and approved by FDA.
Actually during real production, FDA does not only had simple requirement on syringe material, but also declared GRAS(General Recognized as Safe) list. If you are using non-listed material as syringe filling, the manufacturer must give validated data to FDA.
Syringe Material(Packaging Material) related to regulation you need to know:
- Material Homogeneity: this refers to the same batch of syringe or different batches of syringe comes with equality homogeneity of material difference to ensure medicine packaging quality which means everything in syringe filling process can be validated.
- Purity of Syringe Material: this refers to the purity of Medicine during shelf life. A good syringematerial (e.g. Glass Syringe) won’t release any impurity during syringe shelf life.
- Integrity: It includes everything related to Quality, Quantity and safety.
- Side Effects: Most of the medicine comes with Side Effects, Packaging material of medicine considered as one of the reason
- Stability and Efficiency: Whatever the good as the packaging material as, still the medicine gets shelf life. So a very good syringe material helps medicine to avoid humidity, leakage, side effects, non-reaction to medicine, etc. These are all the point we need to consider as stability of syringe material.
Main Issues on Glass Syringe Effects on production:
- Chemical Reaction between medicine and glass syringe
While water based solution contact to glass syringe there will be basic chemical reaction happens:
a. Ion Exchange: H3O–will exchange with Na+ inside glass syringe. I Ion exchange is the dominant mechanism for glass erosion in most acidic and neutral formulations.
b. Another mechanism is the attack of hydroxyl and other alkaline substances on the silica network itself, breaking Si-O bonds.
So the Receipt or how well the Glass Manufacturer prepare Glass syringe will be very important. As the Ph Value of Medicine also cause problem, you need to notice on this.
- Physical Issues mainly happens on heat damage while cooling or heating the syringe during sterilization process. So normally people adopts Hot Air Circulation Type Autoclave for terminal sterilization. This will increase initial equipment investment. So most of LTPM China client’s use RTU Syringe with cRABs or even Isolator for doing syringe filling process.